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Butyrate Therapy for Type 1 Diabetes

Phase 1 & 2
Recruiting
Led By Adrian Vella, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All type 1 diabetes with C-Peptide (CPR) less than 0.5 ng/mL subjects who are > 20 and <80 years of age recruited from the Mayo Clinic Endocrinology Clinic
Will also meet HbA1c level of 6.4-8.9% and BMI of < 30 kg/m2 at week -4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up (day 0) to day 28 and day 56
Awards & highlights

Study Summary

This trial is looking at whether a colon-targeted 500 mg butyrate tablet can help with metabolic control in people with type 1 diabetes.

Who is the study for?
This trial is for adults aged 20-80 with Type 1 Diabetes, who are patients at the Mayo Clinic Endocrinology Clinic. They must have an HbA1c level of 6.4-8.9%, a BMI under 30, and low C-Peptide levels (<0.5 ng/mL). Participants cannot be on any T1D treatments other than insulin and must not be pregnant or unable to consent.Check my eligibility
What is being tested?
The trial is testing BKR-017, which are butyrate tablets aimed at the colon, as an additional treatment to improve metabolic control in people with Type 1 Diabetes.See study design
What are the potential side effects?
Potential side effects of BKR-017 may include digestive discomfort or changes in bowel habits due to its action on the gut; however, specific side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 20 and 80 years old with type 1 diabetes and a C-Peptide level below 0.5 ng/mL.
Select...
My HbA1c is between 6.4-8.9% and my BMI is under 30.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~(day 0) to day 28 and day 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and (day 0) to day 28 and day 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insulin sensitivity
Secondary outcome measures
Glucose Variability and Triglycerides

Trial Design

1Treatment groups
Experimental Treatment
Group I: Conventional Therapy / ButyrateExperimental Treatment1 Intervention
Subjects will be receiving usual therapy for the first study period (approx 1 month) then 500 mg Butyrate tablets to be taken at a dose of 1.5 g (3 tablets) twice daily (BID) for approx 2 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BKR-017
2021
N/A
~80

Find a Location

Who is running the clinical trial?

BioKier Inc.Industry Sponsor
3 Previous Clinical Trials
88 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,764 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,120 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more openings in this clinical examination?

"Clinicaltrials.gov evidences that this medical research is currently searching for volunteers; the initial posting was on July 28th 2022 and it has been recently updated on October 4th of the same year."

Answered by AI

What demographic qualifies for enrollment in this research program?

"In order to qualify for this trial, individuals must have type 1 diabetes mellitus and be between 20-80 years old. Roughly 20 participants are required."

Answered by AI

How many participants are being treated in this medical study?

"Affirmative. It is indicated on clinicaltrials.gov that this medical trial, posted on July 28th 2022 and revised most recently on October 4th 2022, is still recruiting patients with a need for 20 participants from one site."

Answered by AI

Is geriatric patient inclusion a stipulation of this scientific research?

"The protocol for this experiment requires individuals between the ages of 20 and 80. There are 219 trials designed specifically for those under 18, while 921 cater to senior citizens over 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Butyrate Adjuvant Therapy for Type 1 Diabetes
Adrian Vella 2022. "Butyrate Adjuvant Therapy for Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03999853.
All > Type 1 Diabetes
~7 spots leftby Apr 2025
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